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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.
- Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma.
- Determine the toxic effects of this drug given at the MTD in these patients.
- Determine the intratumor and brain distribution of this drug by MRI in these patients.
OUTLINE: This is a dose-escalation study of motexafin gadolinium.
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
motexafin gadolinium, radiation therapy
Children's Hospital Los Angeles
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:27-0400
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